The trial will be conducted according to the design below, in 3 steps:

Step 1: enrollment of 80 patients (40 in each arm)

Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.

Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly > 70%, which translates in a maximum of 6 virologic failures.

No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S

Negative HBs Ag

Informed consent form signed by patient and investigator

A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study

Patient covered with health insurance

Effective contraception

Exclusion Criteria:

HIV-2 infection

Dialysis or severe renal failure (creatinine clearance < 30 ml/min)

History of decompensated liver disease

History of HIV-associated neurocognitive disorders

AST or ALT > 5 x ULN

Positive HBc Ac and negative HBs Ac

Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug

Current pregnancy or breastfeeding

Patient involved in another research that precludes enrolment in another trial

Patient under guardianship, or deprived of liberty by a court or administrative decision.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069834